NCT06682208 ES Catheter vs Cryoablation After Pectus Surgery
| NCT ID | NCT06682208 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Pectus Excavatum |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2024-04-08 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 176 participants in total. It began in 2024-04-08 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Participants will be randomized to receive ES catheter or cryoablation for pain management after the Nuss procedure. The goal of this study is to compare the following between the two groups: * Time to achieve short-term physical therapy goals and long-term functional outcomes * Compare immediate and long-term postoperative opioid use * Compare numbness on chest of postoperative day 1 and the return of sensation to baseline * Compare the incidence of neuropathic pain and other complications Participants will receive surveys for up to 12 months postoperatively.
Eligibility Criteria
Inclusion Criteria: * Age 12 - 21 years * History of pectus excavatum * Scheduled for Nuss procedure Exclusion Criteria: * Prior pectus repair * Other concomitant surgeries * Chronic pain conditions including Ehlers Danlos Syndrome * Non-English speaking - rationale: the questionnaires used in the study are in English language and the social and cultural factors of pain perception of non-English speaking patients could affect the study power * Severe developmental delays including cognitive (difficulties understanding), motor (cerebral palsy or muscular dystrophy), and speech delays (difficulties communicating) * History of or active renal or liver disease * Major surgery requiring opioids in the last 2 years * Severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month) * Cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, uncontrolled hypertension with ongoing treatment, Kawasaki disease, or cardiomyopathies. Participants with asymptomatic valvular lesions or defects may be included * BMI \>35 * Pregnant or breastfeeding females
Contact & Investigator
Charlotte Walter, MD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT06682208 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 21 Years, studying Pectus Excavatum. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06682208 currently recruiting?
Yes, NCT06682208 is actively recruiting participants. Contact the research team at Charlotte.Walter@cchmc.org for enrollment information.
Where is the NCT06682208 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06682208 clinical trial?
NCT06682208 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Charlotte Walter, MD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 176 participants.